Leicester Clinical Trials Unit

About LCTU

Leicester Clinical Trials Unit (LCTU) at the University of Leicester

LCTU functions as a partnership between the University of Leicester and the University Hospitals of Leicester NHS Trust for the delivery high quality of clinical trials. LCTU provide an infrastructure to bring together the expertise of academic clinicians and other health service researchers in Leicester, the East Midlands, the UK and beyond.

LCTU was set up in 2009 by the University of Leicester, with core funding provided through the College of Life Sciences. Following a rigorous registration process 'full registration' status was achieved in 2013 and re-accreditation in 2017.

LCTU remit

LCTU is a UK Clinical Research Collaboration (UKCRC) registered clinical trial unit working with Investigators from across a range of therapeutic areas.

LCTU work in collaboration with researchers, investigators and clinicians to design and conduct high quality multi-site randomised controlled trials (RCTs) with expertise in the following: trial methodology and design; site set-up and central trial management; IT and data management; trial statistics and conducting of final data analysis.

Establishing and maintaining on-going relationships with you, our investigators, is a priority area for LCTU. Investing in a significant level of commitment to each funding application with the common goal of succeeding in high quality funding applications, the delivery of first class research, and the development of a track record of success.

All CTUs (Clinical Trial Units) are managed under a strict UKCRC operating framework and are performance monitored on a yearly basis. The trials LCTU support must, therefore, contribute to the on-going registration process which LCTU are mandated to undergo in order to retain our UKCRC registration. This is achieved by engaging in a true collaboration between all partners, rather than simply providing stand-alone services.

Whilst one of our key performance areas is the support of NIHR funded multi-site RCTs with central CTU oversight (as demonstrated below with an extract from the UKCRC website), LCTU are committed to assessing each collaboration request on its merits.

Academic research

LCTU is an academic unit, providing expertise and support for the management of multi-centre RCTs along with other complex studies. These are delivered to the rules, regulations and standards set out by relevant regulatory authorities such as the Medicines and Healthcare products Regulatory Agency (MHRA), the Health Research Authority (HRA) and in compliance to Good Clinical Practice (GCP) guidelines set out by the International Council for Harmonisation (ICH). They are delivered through the support provided in the form of specified trial-related services such as the building high quality databases. LCTU also provides support to observational or cohort studies that require significant levels of data management.

The majority of Clinical Trials supported by LCTU are sponsored by the University of Leicester, and therefore, we ensure that our processes align with the Standard Operating Procedures (SOPs) supplied by the Research Ethics, Governance and Integrity Office.

LCTU aim to facilitate the conduct of high quality clinical research and ensure the generation of reliable evidence for the management of a wide range of diseases.

As an academic research unit, LCTU are particularly interested in supporting studies that reduce the uncertainties facing medical professionals and patients in daily clinical practice. These studies are typically funded from external sources, such as the National Institute for Health Research (NIHR) funding schemes and medical charities.

LCTU welcome and encourage you to make contact early in the development of your application or protocol. The steps to do this are outlined on the Collaborate with us page.

Core competencies

LCTU support investigators by providing access to our core competencies of

  • Trial design
  • Multi-site trial management
  • Database provision and data management
  • Statistics

The services available from the LCTU include contribution to funding applications, trial design, sample size calculations, protocol development, ethics committee and regulatory submissions, database build and data management, randomisation, trial management, data entry, analysis, and interpretation along with statistical reporting.

Clinical Trials Units and The Cochrane Collaboration

A key part of the infrastructure for clinical trials in the UK is provided by more than 50 clinical trials units across the country, of which Leicester is one. This podcast, featuring Professor Julia Brown, Director of the Clinical Trial Units Network, talks about the value and contribution of Clinical Trials Units for The Cochrane Collaboration and their contribution to ensuring that clinical trials improve lives.

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